Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2025-12-26 @ 10:32 AM
NCT ID:
NCT02431728
Eligibility Criteria:
Inclusion Criteria:
* Males 18 years of age and older who are actively participating in therapy at a residential treatment program
* Willingness to participate in the 4-week study
* Willingness to provide self-reported demographic, social, medical, medication, preventive, and mental health histories
* Willingness to complete self-assessments of anxiety, depression, insomnia, and stress at designated time intervals
* Willingness to administer daily before bed a capsule containing either 5 mg melatonin plus vegetable fiber filler or only the vegetable fiber filler without melatonin (i.e., the matched placebo).
* English speaking
Exclusion Criteria:
* Patients already taking melatonin
* Adverse history with melatonin supplementation
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02431728
Study Brief:
Protocol Section:
NCT02431728